Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 2612 Date: December 14, 2012

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1 S anual System Pub edicare laims Processing Department of Health & Human Services (DHHS) enters for edicare & edicaid Services (S) Transmittal 2612 Date: December 14, 2012 hange equest 8132 Transmittal 2601, dated November 30, 2012, is being rescinded and replaced by Transmittal 2612, dated December 14, 2012, to change the date from November 21, 2013, to November 21, 2012, in the fourth sentence in the paragraph under the Access to Data File heading. All other information remains the same. SUBJET: alendar Year (Y) 2013 Annual Update for linical Laboratory Fee Schedule and Laboratory Services Subject to easonable harge Payment. SUAY OF HANGES: This ecurring Update Notification (UN) provides instructions for the Y 2013 clinical laboratory fee schedule, mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment. The information related to this UN is found in hapter 16, Section 20.2, of Publication EFFETVE DATE: January 1, 2013 PLEENTATON DATE: January 7, 2013 Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.. HANGES N ANUAL NSTUTONS: (N/A if manual is not updated) =EVSED, N=NEW, D=DELETED-Only One Per ow. /N/D N/A HAPTE / SETON / SUBSETON / TTLE. FUNDNG: For Fiscal ntermediaries (Fs), egional Home Health ntermediaries (HHs): No additional funding will be provided by S; ontractors activities are to be carried out with their operating budgets For edicare Administrative ontractors (As): The edicare Administrative contractor is hereby advised that this constitutes technical direction as defined in your contract. S does not construe this as a change to the A statement of Work. The contractor is not obliged to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements. V. ATTAHENTS: Business equirements *Unless otherwise specified, the effective date is the date of service.

2 Attachment - ecurring Update Notification Pub Transmittal: 2612 Date: December 14, 2012 hange equest: 8132 Transmittal 2601, dated November 30, 2012, is being rescinded and replaced by Transmittal 2612, dated December 14, 2012, to change the date from November 21, 2013, to November 21, 2012, in the fourth sentence in the paragraph under the Access to Data File heading. All other information remains the same. SUBJET: alendar Year (Y) 2013 Annual Update for linical Laboratory Fee Schedule and Laboratory Services Subject to easonable harge Payment EFFETVE DATE: January 1, 2013 PLEENTATON DATE: January 7, GENEAL NFOATON A. Background: This ecurring Update Notification (UN) provides instructions for the Y 2013 clinical laboratory fee schedule, mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment. B. Policy: Update to Fees n accordance with Section 1833(h)(2)(A)(i) of the Social Security Act (the Act), as amended by Section 628 of the edicare Prescription Drug, mprovement and odernization Act (A) of 2003, and further amended by Section 3401 of the Patient Protection and Affordable are Act (AA) of 2010 and the iddle lass Tax elief and Job reation Act of 2012, the annual update to the local clinical laboratory fees for Y 2013 is percent. The annual update to local clinical laboratory fees for Y 2013 reflects the onsumer Price ndex for Urban Areas (P-U) of 1.70 percent less a multi-factor productivity adjustment of 0.9 percentage points and a percentage point reduction as described by the AA legislation, plus a -2.0 percentage point reduction as described by the TJA. The annual update to payments made on a reasonable charge basis for all other laboratory services for Y 2013 is 1.7 percent (See 42 F (b)(1)). Section 1833(a)(1)(D) of the Act provides that payment for a clinical laboratory test is the lesser of the actual charge billed for the test, the local fee, or the national limitation amount (NLA). For a cervical or vaginal smear test (pap smear), Section 1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount (described below). However, for a cervical or vaginal smear test (pap smear), payment may also not exceed the actual charge. The Part B deductible and coinsurance do not apply for services paid under the clinical laboratory fee schedule. National inimum Payment Amounts For a cervical or vaginal smear test (pap smear), Section 1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount. Also, payment may not exceed the actual charge. The Y 2013 national minimum payment amount is $14.53 ($14.97 plus (-2.95) percent update for Y 2013). The affected codes for the national minimum payment amount are 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166, 88167, 88174, 88175, G0123, G0143, G0144, G0145, G0147, G0148, and P3000.

3 National Limitation Amounts (aximum) For tests for which NLAs were established before January 1, 2001, the NLA is 74 percent of the median of the local fees. For tests for which the NLAs are first established on or after January 1, 2001, the NLA is 100 percent of the median of the local fees in accordance with Section 1833(h)(4)(B)(viii) of the Act. Access to Data File The Y 2013 clinical laboratory fee schedule data file shall be retrieved electronically through S mainframe telecommunications system. arriers shall retrieve the data file on or after November 14, ntermediaries shall retrieve the data file on or after November 21, nternet access to the Y 2013 clinical laboratory fee schedule data file shall be available after November 21, 2012, at Other interested parties, such as the edicaid State agencies, the ndian Health Service, the United ine Workers, and the ailroad etirement Board, shall use the nternet to retrieve the Y 2013 clinical laboratory fee schedule. t will be available in multiple formats: Excel, text, and comma delimited. Data File Format For each test code, if your system retains only the pricing amount, load the data from the field named 60% Pricing Amt. For each test code, if your system has been developed to retain the local fee and the NLA, you may load the data from the fields named 60% Local Fee Amt and 60% Natl Limit Amt to determine payment. For test codes for cervical or vaginal smears (pap smears), you should load the data from the field named 60% Pricing Amt which reflects the lower of the local fee or the NLA, but not less than the national minimum payment amount. Fiscal intermediaries should use the field 62% Pricing Amt for payment to qualified laboratories of sole community hospitals. Public omments On July 16, 2012, S hosted a public meeting to solicit input on the payment relationship between Y 2012 codes and new Y 2013 PT codes. Notice of the meeting was published in the Federal egisteron ay 29, 2012, and on the S web site approximately June 15, ecommendations were received from many attendees, including individuals representing laboratories, manufacturers, and medical societies. S posted a summary of the meeting and the tentative payment determinations on the web site at Additional written comments from the public were accepted until September 28, S has posted a summary of the public comments and the rationale for the final payment determinations on the S web site. Pricing nformation The Y 2013 clinical laboratory fee schedule includes separately payable fees for certain specimen collection methods (codes 36415, P9612, and P9615). The fees have been established in accordance with Section 1833(h)(4)(B) of the Act. The fees for clinical laboratory travel codes P9603 and P9604 are updated on an annual basis. The clinical laboratory travel codes are billable only for traveling to perform a specimen collection for either a nursing home or homebound patient. f there is a revision to the standard mileage rate for Y 2013, S will issue a separate instruction on the clinical laboratory travel fees. The Y 2013 clinical laboratory fee schedule also includes codes that have a QW modifier to both identify codes and determine payment for tests performed by a laboratory having only a certificate of waiver under the linical Laboratory mprovement Amendments (LA).

4 Organ or Disease Oriented Panel odes Similar to prior years, the Y 2013 pricing amounts for certain organ or disease panel codes and evocative/suppression test codes were derived by summing the lower of the clinical laboratory fee schedule amount or the NLA for each individual test code included in the panel code. The NLA field on the data file is zero-filled. apping nformation New code 86386QW is priced at the same rate as code 86386, effective January 1, New code 83861QW is priced at the same rate as code 83861, effective July 1, New code 86803QW is priced at the same rate as code New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled.

5 New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled.

6 New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled.

7 New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled.

8 New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is to be gap filled. New code is priced at the same rate as code Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted.

9 Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. Existing code is deleted. New code is to be gap filled. New code is priced at the same rate as code New code is priced at the same rate as code New code is priced at the same rate as code New code is priced at 7 times the rate of code New code is priced at 6 times the rate of code New code is priced at 11 times the rate of code New code is priced at 10 times the rate of code New code is priced at 31 times the rate of code New code is priced at 28 times the rate of code New code is priced at the same rate as code plus 2 times the rate of code New code is priced at the same rate as code plus 6 times the rate of code New code is priced at the same rate as code plus 16 times the rate of code New code is priced at the same rate as code New code is priced at the same rate as code Laboratory osts Subject to easonable harge Payment in Y 2013 For outpatients, the following codes are paid under a reasonable charge basis (See Section 1842(b)(3) of the Act). n accordance with 42 F through 42 F , the reasonable charge may not exceed the lowest of the actual charge or the customary or prevailing charge for the previous 12-month period ending June 30, updated by the inflation-indexed update. The inflation-indexed update is calculated using the change in the applicable onsumer Price ndex for the 12-month period ending June 30 of each year as set forth in 42 F (b)(1). The inflation-indexed update for Y 2013 is 1.7 percent.

10 anual instructions for determining the reasonable charge payment can be found in Publication 100-4, edicare laims Processing anual, hapter 23, Section 80 through f there is insufficient charge data for a code, the instructions permit considering charges for other similar services and price lists. When services described by the Healthcare ommon Procedure oding System (HPS) in the following list are performed for independent dialysis facility patients, Publication , edicare laims Processing anual, hapter 8, Section 60.3 instructs that the reasonable charge basis applies. However, when these services are performed for hospital-based renal dialysis facility patients, payment is made on a reasonable cost basis. Also, when these services are performed for hospital outpatients, payment is made under the hospital outpatient prospective payment system (OPPS). Blood Products P9010 P9011 P9012 P9016 P9017 P9019 P9020 P9021 P9022 P9023 P9031 P9032 P9033 P9034 P9035 P9036 P9037 P9038 P9039 P9040 P9044

11 P9050 P9051 P9052 P9053 P9054 P9055 P9056 P9057 P9058 P9059 P9060 Also, payment for the following codes should be applied to the blood deductible as instructed in Publication , edicare General nformation, Eligibility and Entitlement anual, hapter 3, Section 20.5 through : P9010 P9016 P9021 P9022 P9038 P9039 P9040 P9051 P9054 P9056 P9057 P9058 NOTE:Biologic products not paid on a cost or prospective payment basis are paid based on Section 1842(o) of the Act. The payment limits based on Section 1842(o), including the payment limits for codes P9041, P9043, P9045, P9046, P9047, and P9048, should be obtained from the edicare Part B drug pricing files.

12 Transfusion edicine

13 eproductive edicine Procedures

14 BUSNESS EQUEENTS TABLE Use "Shall" to denote a mandatory requirement. Number equirement esponsibility A/B A D E F P a r t P a r t A A E H H Shared- System aintainers F S S S V S W F Other arriers shall retrieve the Y 2013 linical Laboratory Fee Schedule data file (filename: U00.@BF12394.LAB.Y13.V1119) from the S mainframe on or after November 14, A B arriers shall notify S of successful receipt via e- mail to price_file_receipt@cms.hhs.gov stating the name of the file received and the entity for which it was received (e.g., carrier name and number) ontractors shall retrieve the Y 2013 linical Laboratory Fee Schedule data file (filename: U00.@BF12394.LAB.Y13.V1119.F) from the S mainframe on or after November 21, ontractors shall notify S of successful receipt via to price_file_receipt@cms.hhs.gov stating the name of the file received and the entity for which it was received (e.g., fiscal intermediary name and number) ontractors shall manually include ode 86386QW in the linical Laboratory Fee Schedule (LFS) beginning January 1, The ED s do the file loads. The ED s do the file loads.

15 Number equirement esponsibility A/B A D E F P a r t P a r t A A E H H Shared- System aintainers F S S S V S W F Other A B ontractors shall manually include ode 83861QW in the linical Laboratory Fee Schedule (LFS) beginning July 1, ontractors shall not search their files to either retract payment or retroactively pay claims; however, contractors should adjust claims if they are brought to their attention arriers shall determine the reasonable charge for the codes identified as paid under the reasonable charge basis arriers shall determine customary and prevailing charges by using data from July 1, 2011 through June 30, 2012, updated by the inflation-index update for year Y 2013 of 1.7 percent ontractors shall determine payment on a reasonable cost basis when these services are performed for hospital-based renal dialysis facility patients f there is a revision to the standard mileage rate for Y 2013, S shall issue a separate instruction on the clinical laboratory travel fees. S will notif y contr actor s of any revisi ons to the stand ard milea ge rate.. POVDE EDUATON TABLE Number equirement esponsibility

16 A/B A P a r t P a r t D E A F A E H H Other LN Article : A provider education article related to this instruction will be available at shortly after the is released. You will receive notification of the article release via the established "LN atters" listserv. ontractors shall post this article, or a direct link to this article, on their Web sites and include information about it in a listserv message within one week of the availability of the provider education article. n addition, the provider education article shall be included in the contractor s next regularly scheduled bulletin. ontractors are free to supplement LN atters articles with localized information that would benefit their provider community in billing and administering the edicare program correctly. A B V. SUPPOTNG NFOATON Section A: ecommendations and supporting information associated with listed requirements: N/A Use "Should" to denote a recommendation. -ef equirement Number ecommendations or other supporting information: Section B: All other recommendations and supporting information: N/A V. ONTATS Pre-mplementation ontact(s): Glenn cguirk, or Glenn.cGuirk@cms.hhs.gov Post-mplementation ontact(s): ontact your ontracting Officer's epresentative (O) or ontractor anager, as applicable. V. FUNDNG Section A: For Fiscal ntermediaries (Fs), egional Home Health ntermediaries (HHs): No additional funding will be provided by S; ontractors activities are to be carried out with their operating budgets Section B: For edicare Administrative ontractors (As): The edicare Administrative ontractor is hereby advised that this constitutes technical direction as defined in your contract. S do not construe this as a change to the A Statement of Work. The contractor is not obligated to incur costs in excess of the amounts allotted in your contract unless and until specifically authorized by the ontracting Officer. f the contractor considers anything provided, as described above, to be outside the current scope of work, the contractor shall withhold performance on the part(s) in question

17 and immediately notify the ontracting Officer, in writing or by , and request formal directions regarding continued performance requirements.

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